Rosuvastatin pretreatment in patients undergoing elective PCI to reduce the incidence of myocardial periprocedural necrosis: The ROMA trial

Sardella, Gennaro; Conti, Giulia; Donahue, Michael; Mancone, Massimo; Canali, Emanuele; Carlo, Carlotta De; Roma, Angelo Di; Calcagno, Simone; Lucisano, Luigi; Fedele, Francesco

doi:10.1002/ccd.24403

Cited by 27 publications

(33 citation statements)

References 21 publications

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“…This change may be attributed to a significant reduction of nonfatal myocardial infarctions. The incidence of PMI in our trial was higher than that in the ARMYDAR-ACS [4] or ROMA trials [5]. The different diagnostic criteria of PMI may have led to this result; in the latter trials, PMI was diagnosed by the increase of creatine kinase-MB instead of cTn I.…”

Section: Discussionmentioning

confidence: 50%

“…Clinical trials have revealed the efficacy of high-dose statin treatment in significantly reducing the incidence of PMI among patients after coronary revascularization [3–5]. However, high-dose statin administration has been associated with severe side effects, including increased risk of new-onset diabetes, liver damage, rhabdomyolysis, and intracerebral haemorrhage [6–8].…”

Section: Introductionmentioning

confidence: 99%

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Efficacy of Danlou Tablet in Patients with Non-ST Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Results from a Multicentre, Placebo-Controlled, Randomized Trial

Wang

Zhao

Mao

et al. 2016

Evidence-Based Complementary and Alternative Medicine

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This study seeks to investigate potential cardioprotection of Danlou Tablets in patients undergoing PCI with non-ST elevation acute coronary syndrome (NSTE-ACS). 219 patients with NSTE-ACS were randomised to Danlou Tablet pretreatment (n = 109) or placebo (n = 110). No patients received statins prior to PCI and all patients were given atorvastatin (10 mg/day) after procedure. The main endpoint was the composite incidence of major adverse cardiac events (MACEs) within 30 days after PCI. The proportion of patients with elevated levels of cTn I>5 × 99% of upper reference limit was significantly lower in the Danlou Tablet group at 8 h (22.0% versus 34.5%, p = 0.04) and 24 h (23.9% versus 38.2%, p = 0.02) after PCI. The 30-day MACEs occurred in 22.0% of the Danlou Tablet group and 33.6% in the placebo group (p = 0.06). The incidence of MACE at 90-day follow-up was significantly decreased in the Danlou Tablet group compared to the placebo group (23.9% versus 37.3%, p = 0.03). The difference between the groups at 90 days was the incidence of nonfatal myocardial infarction (22% versus 34.5%, p = 0.04). These findings might support that treatment with Danlou Tablet could reduce the incidence of periprocedural myocardial infarction in patients with ACS undergoing PCI.

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Section: Discussionmentioning

confidence: 50%

Section: Introductionmentioning

confidence: 99%

Efficacy of Danlou Tablet in Patients with Non-ST Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Results from a Multicentre, Placebo-Controlled, Randomized Trial

Wang

Zhao

Mao

et al. 2016

Evidence-Based Complementary and Alternative Medicine

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“…Accordingly, the ROSEMARY study [28] suggests that early high-dose rosuvastatin therapy (40 mg before treatment plus maintenance for 7 days) in patients with ST elevation MI undergoing primary PCI did not improve periprocedural myocardial perfusion or reduce infarct volume measured by magnetic resonance imaging compared with the conventional low-dose rosuvastatin regimen. On the contrary, in the ROMA trial, high loading dose of rosuvastatin (40 mg) within 24 h before elective PCI decreased the incidence of periprocedural MI compared to the standard treatment [29]. Furthermore, Takano et al [30] reported that the incidence of periprocedural MI was reduced more effectively by high-dose than by low-dose rosuvastatin in statin-näive patients.…”

Section: Discussionmentioning

confidence: 95%

“…Periprocedural MI is defined as an elevation of troponin (either I or T) values >5 x 99th percentile upper reference limit (URL) in patients with normal baseline values (≤99th percentile URL) or a rise of troponin values >20 % if the baseline values were elevated and are stable or falling [29]. Secondary endpoints are: 1) the combined occurrence of 1-month major adverse cardiovascular events (MACE, including death, MI, stroke or the need for unplanned revascularization) in the 4 treatment arms.…”

Section: Study Endpointsmentioning

confidence: 99%

Rosuvastatin for Reduction of Myocardial Damage during Coronary Angioplasty - the Remedy Trial

Briguori

Madonna

Zimarino

et al. 2016

Cardiovasc Drugs Ther

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The REMEDY study will enroll a total of 1080 patients submitted to elective PCI. Eligible patients will be randomized into 4 groups: 1) placebo; 2) atorvastatin (80 mg + 40 mg before PCI); 3) rosuvastatin (40 mg twice before PCI); and 4) rosuvastatin (5 mg) and ezetimibe (10 mg) twice before PCI. Peri-procedural MI is defined as an elevation of markers of cardiac injury (either CK-MB or troponin I or T) values >5x the upper reference limit estimated at the 99th percentile of the normal distribution, or a rise >20 % in case of baseline values already elevated. EPCs will be assessed before, at 24 h and - in a subset of diabetic patients - at 3 months after PCI (EPC-substudies). The primary endpoint of the main REMEDY study is the rate of peri-procedural MI in each of the 4 treatment arms. Secondary endpoints are the combined occurrence of 1-month major adverse events (MACE, including death, MI, or the need for unplanned revascularization); and any post-procedural increase in serum creatinine. Endpoints of the EPC-substudies are the impact of tested regimens on 1) early (24-h) and 3-month EPC levels and functional activity; 2) stent strut re-endothelialization and neointimal hyperplasia; 3) 1-year MACE. REMEDY will add important information on the cardioprotective effects of statins after PCI.

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“…Many data support the pleiotropic effect of statins showing a rapid anti-inflammatory and antioxidant effects with consequently a myocardial protection by reperfusion damage (13,14). The concentration of C-reactive protein after statin therapy, decrease in some studies (15)(16)(17).…”

mentioning

confidence: 94%

The statin therapy to prevent atrial fibrillation after cardiac surgery: Shakespearean dilemma

Calcagno¹,

Stio²,

Mancone³

et al. 2016

J. Thorac. Dis.

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Rosuvastatin pretreatment in patients undergoing elective PCI to reduce the incidence of myocardial periprocedural necrosis: The ROMA trial

Abstract: High loading dose of rosuvastatin within 24 hr before elective PCI seems to decrease the incidence of periprocedural myocardial necrosis during a period of 12-months compared to the standard treatment.

Cited by 27 publications

References 21 publications

Efficacy of Danlou Tablet in Patients with Non-ST Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Results from a Multicentre, Placebo-Controlled, Randomized Trial

Efficacy of Danlou Tablet in Patients with Non-ST Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Results from a Multicentre, Placebo-Controlled, Randomized Trial

Rosuvastatin for Reduction of Myocardial Damage during Coronary Angioplasty - the Remedy Trial

The statin therapy to prevent atrial fibrillation after cardiac surgery: Shakespearean dilemma

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